Device product
Respirator Crash Cart Kit
Z-2466-2020
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 85736
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 kits
- Official record key
device-enforcement:Z-2466-2020
Official wording
Reason: Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
Code information: Item #: 830066; Lot #: 77127, 74813 and 63168 Expiration date per lot: Lot: 77127, Exp date: 1/31/2021 Lot: 74813, Exp date: 8/30/2021 Lot: 63168, Exp date: 1/30/2021
Distribution pattern: Domestic distribution only to: MO and LA.
Derived failure modes
-
Labeling or packaging
labeling error